The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1131-2016·Announced 2016-07-13

Reliable Compounding Pharmacy Recalls All Compounded Tacrolimus Products

Reliable Compounding Pharmacy is recalling all compounded tacrolimus products due to a lack of processing controls. The recall covers products distributed in California, Hawaii, and New Mexico.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) when no specific injuries or illnesses are reported in the source text, and the hazard is a lack of processing controls rather than a specific pathogen or structural defect.

Plain-English summary

Reliable Rexall-A Compounding Pharmacy is recalling all compounded tacrolimus products. The recall is being conducted due to a lack of processing controls. The affected products are prescription-only medications compounded by Reliable Drug/Reliable Compounding Pharmacy located in San Francisco, California.

The recall includes all lots compounded between March 24, 2015, and March 24, 2016, that are within their expiration dates. The products were distributed in the United States, specifically in California, Hawaii, and New Mexico.

Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for further instructions. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
All tacrolimus Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
Manufacturer
Reliable Rexall-A Compounding Pharmacy
Category
Drug — Compounded Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots compounded between 03/24/2015 and 03/24/2016 and within expiry..

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 70 recalled by Reliable Rexall-A Compounding Pharmacy under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 70 products in this recall →

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